Medical fluid generation system

ABSTRACT

A medical fluid generation system is disclosed. In an example, a peritoneal dialysis fluid generation system includes water purification equipment configured to provide purified water; a presterilized tubing set including a container for storing peritoneal dialysis fluid; at least one glucose or buffer concentrate; and a hemodialysis machine in fluid communication with the water purification equipment. The hemodialysis machine includes at least one mixing pump for mixing the at least one glucose or buffer concentrate with the purified water to form peritoneal dialysis fluid, a dialysis fluid pump for delivering the peritoneal dialysis fluid to the container, and a control unit configured to control the at least one mixing pump to form the peritoneal dialysis fluid and the dialysis fluid pump to deliver the peritoneal dialysis fluid to the container.

BACKGROUND

The present disclosure relates generally to medical fluid treatments andin particular to dialysis fluid treatments.

Due to various causes, a person's renal system can fail. Renal failureproduces several physiological derangements. It is no longer possible tobalance water and minerals or to excrete daily metabolic load. Toxic endproducts of metabolism, such as, urea, creatinine, uric acid and others,may accumulate in a patient's blood and tissue.

Reduced kidney function and, above all, kidney failure is treated withdialysis. Dialysis removes waste, toxins and excess water from the bodythat normal functioning kidneys would otherwise remove. Dialysistreatment for replacement of kidney functions is critical to many peoplebecause the treatment is lifesaving.

One type of kidney failure therapy is Hemodialysis (“HD”), which ingeneral uses diffusion to remove waste products from a patient's blood.A diffusive gradient occurs across the semi-permeable dialyzer betweenthe blood and an electrolyte solution called dialysate or dialysis fluidto cause diffusion. HD fluids are typically created by the dialysismachines by mixing concentrates and clean water.

Hemofiltration (“HF”) is an alternative renal replacement therapy thatrelies on a convective transport of toxins from the patient's blood. HFis accomplished by adding substitution or replacement fluid to theextracorporeal circuit during treatment. The substitution fluid and thefluid accumulated by the patient in between treatments is ultrafilteredover the course of the HF treatment, providing a convective transportmechanism that is particularly beneficial in removing middle and largemolecules.

Hemodiafiltration (“HDF”) is a treatment modality that combinesconvective and diffusive clearances. HDF uses dialysis fluid flowingthrough a dialyzer, similar to standard hemodialysis, to providediffusive clearance. In addition, substitution solution is delivereddirectly to the extracorporeal circuit, providing convective clearance.Here, more fluid than the patient's excess fluid is removed from thepatient, causing the increased convective transport of waste productsfrom the patient. The additional fluid removed is replaced via thesubstitution or replacement fluid.

Another type of kidney failure therapy is peritoneal dialysis (“PD”),which infuses a dialysis solution, also called dialysis fluid, into apatient's peritoneal cavity via a catheter. The dialysis fluid is incontact with the peritoneal membrane in the patient's peritoneal cavity.Waste, toxins and excess water pass from the patient's bloodstream,through the capillaries in the peritoneal membrane, and into thedialysis fluid due to diffusion and osmosis, i.e., an osmotic gradientoccurs across the membrane. An osmotic agent in the PD dialysis fluidprovides the osmotic gradient. Used or spent dialysis fluid is drainedfrom the patient, removing waste, toxins and excess water from thepatient. This cycle is repeated, e.g., multiple times. PD fluids aretypically prepared in a factory and shipped to the patient's home inready-to-use bags.

There are various types of peritoneal dialysis therapies, includingcontinuous ambulatory peritoneal dialysis (“CAPD”), automated peritonealdialysis (“APD”), tidal flow dialysis and continuous flow peritonealdialysis (“CFPD”). CAPD is a manual dialysis treatment, where fluidtransport is driven by gravity. If initially full of used dialysisfluid, the patient manually connects an implanted catheter to a drain toallow the used or spent dialysis fluid to drain from the patient'speritoneal cavity. The patient then switches fluid communication so thatthe patient catheter communicates with a bag of fresh dialysis fluid toinfuse the fresh dialysis fluid through the catheter and into thepatient. The patient disconnects the catheter from the fresh dialysisfluid bag and allows the dialysis fluid to dwell within the peritonealcavity, wherein the transfer of waste, toxins and excess water takesplace. After a dwell period, the patient repeats the manual dialysisprocedure, for example, four times per day. If the patient is notinitially full of used dialysis fluid, the sequence is instead fill,dwell and drain. Manual peritoneal dialysis requires a significantamount of time and effort from the patient, leaving ample room forimprovement.

Automated peritoneal dialysis (“APD”) is similar to CAPD in that thedialysis treatment includes drain, fill and dwell cycles. APD machines,however, perform the cycles automatically, typically while the patientsleeps. APD machines free patients from having to manually perform thetreatment cycles and from having to transport supplies during the day.APD machines connect fluidly to an implanted catheter, to a source orbag of fresh dialysis fluid and to a fluid drain. APD machines pumpfresh dialysis fluid from a dialysis fluid source, through the catheterand into the patient's peritoneal cavity. APD machines also allow forthe dialysis fluid to dwell within the chamber and for the transfer ofwaste, toxins and excess water to take place. The source may includemultiple liters of dialysis fluid including several solution bags.

APD machines pump used or spent dialysate from the peritoneal cavity,through the catheter, and to the drain. As with the manual process,several drain, fill and dwell cycles occur during dialysis. A “lastfill” may occur at the end of the APD treatment. The last fill fluid mayremain in the peritoneal cavity of the patient until the start of thenext treatment, or may be manually emptied at some point during the day.

A large percentage of blood treatments, such as HD, HF and HDFtreatments, take place in a clinic or center. The blood machines in theclinics or centers are typically used throughout the day. Nevertheless,there exists a fairly significant period of time after the clinic orcenter closes, where the machines are not used. A certain amount of timeis needed for the machines to run a thorough disinfection sequence priorto the next day's treatments, but even still, a substantial amount oftime remains during which the blood machines are dormant and unused.

A need exists accordingly to provide an improved system to maximize thedialysis fluid producing potential of in-center dialysis machines, suchas hemodialysis machines, which allows patients to be treated at homeinstead of having to travel back and forth to a clinic, and which allowsin-center dialysis machines to help in times of increased demand orurgent need of dialysis fluids such as PD fluids.

SUMMARY

The present disclosure sets forth systems and methods for producingperitoneal dialysis (“PD”) fluid and other fluids using one or morein-center hemodialysis (“HD”) machine. While the present disclosurefocuses mainly on PD fluid, the teachings discussed herein alsoapplicable to other treatment and injectable fluids, such as continuousrenal replacement treatment (“CRRT”) fluids including HD fluids,substitution or replacement fluids for hemofiltration (“HF”) andhemodiafiltration (“HDF”), saline, lactated ringers and the like. Thein-center hemodialysis machine receives purified water from a centralwater purification station in one embodiment. In a PD fluid example, thepurified water is mixed with PD concentrates when making PD fluid,including electrolyte, glucose and buffer concentrates, and is thendelivered via a presterilized tubing set to one or more presterilizedstorage container or bag. One or more terminal or sterile sterilizinggrade filters, e.g., integral to the final solution container, is/areprovided with the tubing set to sterilize the PD fluid to the point thatit may be delivered to a patient's peritoneal cavity (or elsewhere forthe other fluids listed above). In one embodiment, the one or morefilters is/are provided in the tubing set upstream of multiplecontainers or bags, which are ganged in series, in parallel or both inthe same tubing set. Alternatively or additionally, a sterilesterilizing grade filter is arranged downstream of the container or bag.

A pressure transmission line may be provided in the tubing set, whichextends from a point just upstream from the one or more sterilesterilizing grade filters back to a pressure port (normally used forarterial or venous pressure) of the hemodialysis machine, and whichallows the PD fluid pressure to be measured while one or more containersare filled. When the pressure along the pressure transmission linechanges by a characteristic amount, filling is complete and thehemodialysis machine stops PD fluid production and delivery.Alternatively, any of the systems described herein may use othervolumetric controls, such as, counting known stroke volumes of the pumpof the dialysis machine that is used to pump the dialysis fluid, using abalance chamber, using a known flowrate and time, using a weigh scale,and/or using a sensor at the container or bag for detecting a filledliquid level, e.g., an optical or capacitance sensor. It is alsocontemplated that any of the systems described herein may fill multiplecontainers or bags as part of the disposable set of containers or bags,e.g., in series, parallel or both.

In one embodiment, a return line is provided from the filled containersto the hemodialysis machine. The return line allows for a PD fluidsample to be taken and analyzed in the machine. The machine may, forexample, provide an onboard conductivity sensor in the machine's drainline (and optionally a glucose sensor), which may be accessed toevaluate the sample. If needed, one or more sterile sterilizing gradefilters may be provided in the return line to prevent contamination ofthe sample and the PD fluid residing upstream in the container andtubing set.

In another embodiment, a standalone valve station may be provided, whichis positioned to operate with the fill lines leading to a plurality ofPD fluid containers or bags. The standalone valve station may be adelegate-type unit that takes commands from the hemodialysis machine.The valve station selectively opens and closes the fill lines accordingto a desired filling pattern, which allows a desired container, or groupof containers, to be filled with PD fluid at a certain time and in acertain order. The valve station also allows different chemicalformulations of PD (or other treatment) fluids to be produced anddelivered to different containers of the tubing set.

In an alternative embodiment, instead of filling the containers or bagswith finished PD (or other treatment) fluid, the hemodialysis machinesform distinct component solutions that are delivered to separatechambers of a dual chamber container. For PD, the hemodialysis machinein any order mixes glucose concentrate with purified water to produce aglucose solution, which is then delivered to a glucose solution chamberof one or more containers. The hemodialysis machine mixes bufferconcentrate with purified water to produce a buffer solution, which isthen delivered to a buffer solution chamber of the one or morecontainers. The glucose and buffer chambers are separated by a frangibleseal, for example, which a patient or caregiver opens at the time ofuse. The component solutions are then mixed to form an overall PD fluidfor treatment. Separating the PD fluid into component solutions forstorage may increase the overall shelf life of container product. Anoverpouch may also be provided to cover the multi-chamber containers toprotect the component solutions from degradation over time.

CRRT fluids including HD fluids, substitution or replacement fluids forHF and HDF, saline, lactated ringers and the like use differentconcentrates than PD fluid and therefore yield different concentratesolutions in the dual chamber container. It is also contemplated toprovide at least one additional chamber as desired, for a third orfurther additional component solution, e.g., an additional glucosesolution for a final PD fluid. In a further alternative embodiment, anyof the chambers, including the additional third chamber may be prefilledwith a component solution, which is also presterilized. In a threechamber container example, one chamber may be prefilled, while the othertwo chambers are filled via the hemodialysis machine.

Any of the systems described herein may operate additionally with areusable filter, such as an ultrafilter or a dialyzer, which may forexample be mounted at the dialysis machine. In an ultrafilter example,the ultrafilter inlet is connected to a reusable hemodialysis machinesupply line, while the ultrafilter outlet is connected to thepresterilized tubing set of the single chamber or multi-chambercontainer systems described herein. The tubing sets may not need one ormore additional sterile sterilizing grade filter, however, such one ormore filter may be provided, for example, to protect against anycontamination resulting from the connection of the presterilized tubingset to the ultrafilter or dialyzer. The reusable filters provideadditional or alternative sterilization.

Any of the filled PD (or other treatment) fluid containers discussedherein may be separated from a remainder of a tubing or disposable setusing a handheld heat sealer, which seals a tube closed directlyadjacent to the container. Once sealed (or double sealed for extrasafety) the tube may be cut using scissors or the heat sealer itself.The separate filled PD fluid container may then be labeled andtransported for packaging and delivery, e.g., to a home PD patient'sresidence. Labels may be printed at the hemodialysis machine, at aseparate dedicated label printer or at a standard printer, e.g., viainstructions sent from the hemodialysis machine.

In light of the disclosure set forth herein, and without limiting thedisclosure in any way, in a first aspect, which may be combined with anyother aspect or portion thereof described herein, a peritoneal dialysisfluid generation system includes water purification equipment configuredto provide purified water; a presterilized tubing set including acontainer for storing peritoneal dialysis fluid; at least one glucose orbuffer concentrate; and a hemodialysis machine in fluid communicationwith the water purification equipment, the hemodialysis machineincluding at least one mixing pump for mixing the at least one glucoseor buffer concentrate with the purified water to form peritonealdialysis fluid, a dialysis fluid pump for delivering the peritonealdialysis fluid to the container, and a control unit configured tocontrol the at least one mixing pump to form the peritoneal dialysisfluid and the dialysis fluid pump to deliver the peritoneal dialysisfluid to the container.

In a second aspect, which may be combined with any other aspect orportion thereof described herein, the hemodialysis machine includes atleast one of (i) at least one conductivity sensor or (ii) a glucosesensor outputting to the control unit as feedback to form the peritonealdialysis fluid.

In a third aspect, which may be combined with any other aspect orportion thereof described herein, the water purification equipmentincludes a central water purification station configured to feed aplurality of hemodialysis machines or a standalone water purifierconfigured to feed the hemodialysis machine.

In a fourth aspect, which may be combined with any other aspect orportion thereof described herein, the control unit is configured toenable an operator to enter at least one of (i) a volume of peritonealdialysis fluid per container or (ii) a number of containers to be filledwith peritoneal dialysis fluid.

In a fifth aspect, which may be combined with any other aspect orportion thereof described herein, the peritoneal dialysis fluidgeneration system includes a filter located in the tubing set upstreamfrom the container, the filter configured to further purify theperitoneal dialysis fluid for delivery to a patient's peritoneal cavity.

In a sixth aspect, which may be combined with any other aspect orportion thereof described herein, the control unit is configured toperform a pressure integrity test on the filter.

In a seventh aspect, which may be combined with any other aspect orportion thereof described herein, the peritoneal dialysis fluidgeneration system includes a pressure transmission line in fluidcommunication with the container, the pressure transmission lineconfigured to transmit peritoneal dialysis fluid dialysis fluid pressureto a pressure transducer of the hemodialysis machine, the control unitconfigured to look for a characteristic change in peritoneal dialysisfluid pressure to stop the dialysis fluid pump from delivering thedialysis fluid to the container.

In an eighth aspect, which may be combined with any other aspect orportion thereof described herein, the container is a first container,and which includes a second container placed fluidly in series with thefirst container.

In a ninth aspect, which may be combined with any other aspect orportion thereof described herein, the container is a first container,and which includes a second container placed fluidly in parallel withthe first container.

In a tenth aspect, which may be combined with any other aspect orportion thereof described herein, the container is a first container,and which includes a second container placed fluidly in series with thefirst container and a third container placed fluidly in parallel withthe first container.

In an eleventh aspect, which may be combined with any other aspect orportion thereof described herein, the container is a first container,and which includes a second container for receiving the peritonealdialysis fluid, the system including a first filling tube leading to thefirst container and a second filling tube leading to the secondcontainer, and which includes first and second clamps on the outside ofthe hemodialysis machine for selectively opening or occluding the firstand second filling tubes.

In a twelfth aspect, which may be combined with any other aspect orportion thereof described herein, the container is a first container,and which includes a second container for receiving the peritonealdialysis fluid, the system including a first filling tube leading to thefirst container and a second filling tube leading to the secondcontainer, and which further includes a standalone valve station forselectively opening or occluding the first and second filling tubes.

In a thirteenth aspect, which may be combined with any other aspect orportion thereof described herein, the standalone valve station is inwired or wireless communication with the control unit of thehemodialysis machine for commanding the standalone valve station.

In a fourteenth aspect, which may be combined with any other aspect orportion thereof described herein, the system is configured to operatethe standalone valve station to deliver the peritoneal dialysis fluid ina first formulation to the first container and to deliver the peritonealdialysis fluid in a second formulation to the second container.

In a fifteenth aspect, which may be combined with any other aspect orportion thereof described herein, the peritoneal dialysis fluidgeneration system includes a return line from the container to thehemodialysis machine for testing the peritoneal dialysis fluid, andwherein the testing optionally includes composition or sterilitytesting.

In a sixteenth aspect, which may be combined with any other aspect orportion thereof described herein, wherein at least one of (i) thepurified water is sterilized water or (ii) the system includes a heatsealer for sealing closed a filling line leading to the container.

In a seventeenth aspect, which may be combined with any other aspect orportion thereof described herein, a medical fluid generation systemincludes water purification equipment configured to provide purifiedwater; a container including a first chamber and a second chamber; afirst concentrate; a second concentrate; and a hemodialysis machine influid communication with the water purification equipment, thehemodialysis machine including at least one mixing pump for mixing thefirst and second concentrates with purified water to form a firstsolution and a second solution, at least one dialysis fluid pump fordelivering the first solution and the second solution, and a controlunit configured to control the at least one mixing pump to form thefirst solution and the second solution and the at least one dialysisfluid pump to deliver the first solution to the first chamber of thecontainer and the second solution to the second chamber of thecontainer.

In an eighteenth aspect, which may be combined with any other aspect orportion thereof described herein, the medical fluid generation system isa peritoneal dialysis fluid generation system, and wherein the firstconcentrate is a buffer concentrate and the second concentrate is aglucose concentrate.

In a nineteenth aspect, which may be combined with any other aspect orportion thereof described herein, wherein the container is a firstcontainer and which includes a second container having first and secondchambers, and wherein the control unit is configured to deliver thefirst solution to the first chamber of each of the first and secondcontainers and the second solution to the second chamber of each of thefirst and second containers.

In a twentieth aspect, which may be combined with any other aspect orportion thereof described herein, the container is provided as part of atubing set including a first filling line leading to the first chamberof the container and a second filling line leading to a second chamberof the container.

In a twenty-first aspect, which may be combined with any other aspect orportion thereof described herein, the tubing set includes a filterlocated upstream and/or downstream of the first and second fillinglines.

In a twenty-second aspect, which may be combined with any other aspector portion thereof described herein, the tubing set includes (i) a firstmanifold line in fluid communication with a plurality of first fillinglines leading to the first chambers of a plurality of the containers and(ii) a second manifold line in fluid communication with a plurality ofsecond filling lines leading to the second chambers of the plurality ofthe containers.

In a twenty-third aspect, which may be combined with any other aspect orportion thereof described herein, the first and second chambers of thecontainer are separated by at least one frangible seal, the frangibleseal openable to allow the first solution to mix with the secondsolution.

In a twenty-fourth aspect, which may be combined with any other aspector portion thereof described herein, the medical fluid generation systemincludes a filter located upstream from the container, the filterconfigured to further purify the first solution and the second solutionfor delivery to a patient's peritoneal cavity after mixing.

In a twenty-fifth aspect, which may be combined with any other aspect orportion thereof described herein, the container includes a third chamberprefilled with a third solution different than the first and secondsolutions.

In a twenty-sixth aspect, which may be combined with any other aspect orportion thereof described herein, the container includes a third chamberprefilled with a third solution made from one of the first or secondconcentrates.

In a twenty-seventh aspect, which may be combined with any other aspector portion thereof described herein, the container includes a thirdchamber, and wherein the control unit is further configured to controlthe at least one mixing pump to form a third solution from a thirdconcentrate and the at least one dialysis fluid pump to deliver thethird solution to the third chamber of the container.

In a twenty-eighth aspect, which may be combined with any other aspector portion thereof described herein, the container includes a thirdchamber, and wherein the control unit is further configured to controlthe at least one mixing pump to form a third solution from one of thefirst or second concentrates and the at least one dialysis fluid pump todeliver the third solution to the third chamber of the container.

In a twenty-ninth aspect, which may be combined with any other aspect orportion thereof described herein, a medical fluid generation systemincludes water purification equipment configured to provide purifiedwater; a container for storing medical fluid; a pressure transmissionline in fluid communication with the container and configured totransmit medical fluid pressure; at least one concentrate for themedical fluid; and a hemodialysis machine in fluid communication withthe water purification equipment, the hemodialysis machine including apressure transducer positioned and arranged to sense the medical fluidpressure in the pressure transmission line, at least one mixing pump foradding the at least one concentrate with the purified water to form themedical fluid, a dialysis fluid pump for delivering the medical fluid tothe container, and a control unit configured to (i) control the at leastone mixing pump to form the medical fluid, (ii) control the dialysisfluid pump to deliver the medical fluid to the container, and (iii) lookfor a characteristic change in medical fluid pressure to stop thedialysis fluid pump from delivering the medical fluid to the container.

In a thirtieth aspect, which may be combined with any other aspect orportion thereof described herein, the characteristic change in medicalfluid pressure is a characteristic change in static medical fluidpressure.

In a thirty-first aspect, which may be combined with any other aspect orportion thereof described herein, a medical fluid generation systemincludes water purification equipment configured to provide purifiedwater; a container including a first chamber for storing purified waterand at least one second chamber prefilled with a concentrate for themedical fluid; and a hemodialysis machine in fluid communication withthe water purification equipment, the hemodialysis machine including afluid pump for delivering the purified water to the first chamber of thecontainer.

In a thirty-second aspect, which may be combined with any other aspector portion thereof described herein, the plurality of chambers areseparated by at least one frangible seal openable to allow the purifiedwater to mix with the at least one concentrate.

In a thirty-third aspect, which may be combined with any other aspect orportion thereof described herein, the purified water mixed with theconcentrate forms peritoneal dialysis fluid.

In a thirty-fourth aspect, which may be combined with any other aspector portion thereof described herein, a tubing set for use with a machinethat generates a medical fluid, wherein the tubing set includes a linefor connecting to the machine or to a fluid carrying structure extendingfrom the machine; at least one sterile sterilizing grade filter locatedalong the line; a manifold structure in fluid communication with theline; a plurality of fill lines in fluid communication with the manifoldstructure; and a plurality of medical fluid containers, each fill linein fluid communication with one of the medical fluid containers, whereineach of the line, the at least one sterile sterilizing grade filter, themanifold structure, the plurality of fill lines and the plurality ofmedical fluid containers are connected and sterilized prior to use.

In a thirty-fifth aspect, which may be combined with any other aspect orportion thereof described herein, the manifold structure is a manifoldconnector.

In a thirty-sixth aspect, which may be combined with any other aspect orportion thereof described herein, the tubing set includes patient tubingprovided with each of the medical fluid containers.

In a thirty-seventh aspect, which may be combined with any other aspector portion thereof described herein, the patient tubing is provided inan overpouch.

In a thirty-eighth aspect, which may be combined with any other aspector portion thereof described herein, the overpouch additionally coversthe respective medical fluid container.

In a thirty-ninth aspect, which may be combined with any other aspect orportion thereof described herein, the plurality of medical fluidcontainers are placed fluidically in parallel via fluid communicationwith the fill lines and the manifold structure.

In a fortieth aspect, which may be combined with any other aspect orportion thereof described herein, at least one of the plurality ofmedical fluid containers is placed fluidically in series with anadditional medical fluid container.

In a forty-first aspect, which may be combined with any other aspect orportion thereof described herein, at least one of the plurality ofmedical fluid containers is placed fluidically in series with a firstadditional medical fluid container and fluidically in parallel with asecond additional medical fluid container.

In a forty-second aspect, which may be combined with any other aspect orportion thereof described herein, the tubing set includes a return lineextending from at least one of the medical fluid containers forconnection to the machine or to a machine line extending from themachine and optionally wherein the return line includes at least onesterile sterilizing filter.

In a forty-third aspect, which may be combined with any other aspect orportion thereof described herein, the fluid carrying structure extendingfrom the machine includes an ultrafilter or dialyzer having an inletline configured to connect to the machine or a line extending from themachine.

In a forty-fourth aspect, which may be combined with any other aspect orportion thereof described herein, the tubing set is assembled andsterilized originally in a first package and the ultrafilter or dialyzerand inlet line are assembled and sterilized originally in a secondpackage.

In a forty-fifth aspect, which may be combined with any other aspect orportion thereof described herein, a tubing set for use with a machinethat generates a medical fluid, wherein the tubing set includes a linefor connecting to the machine or to a fluid carrying structure extendingfrom the machine; a Y or T-connector in fluid communication with theline; a first manifold line in fluid communication with the Y orT-connector; a second manifold line in fluid communication with the Y orT-connector; a plurality of multi-chamber medical fluid containers eachincluding a first chamber and a second chamber; a plurality of firstfilling lines in fluid communication with the first manifold line andthe first chambers of the plurality of multi-chamber medical fluidcontainers; a plurality of second filling lines in fluid communicationwith the second manifold line and the second chambers of the pluralityof multi-chamber medical fluid containers; and at least one sterilesterilizing filter located (i) upstream of the Y or T-connector or (ii)in each of the first and second manifold lines.

In a forty-sixth aspect, which may be combined with any other aspect orportion thereof described herein, the Y or T-connector is a first Y orT-connector, and which includes a second Y or T-connector located (i)between a leg of the first Y or T-connector and one of first or secondmanifold lines or (ii) upstream of the at least one sterile sterilizingfilter when the at least one sterile sterilizing filter is locatedupstream of the first Y or T-connector, and wherein a disposable drainline extends from a leg of the second Y or T-connector.

In a forty-seventh aspect, which may be combined with any other aspector portion thereof described herein, at least one of the multi-chambermedical fluid containers includes a third chamber, the third chamberprefilled with a component solution.

In a forty-eighth aspect, which may be combined with any other aspect orportion thereof described herein, at least one of the multi-chambermedical fluid containers includes a third chamber, and which includes athird filling line in fluid communication with the third chamber and inselective fluid communication with the line for connecting to themachine or to a fluid carrying structure extending from the machine.

In a forty-ninth aspect, which may be combined with any other aspect orportion thereof described herein, the fluid carrying structure extendingfrom the machine includes an ultrafilter or dialyzer having an inletline configured to connect to the machine or a line extending from themachine.

In a fiftieth aspect, which may be combined with any other aspect orportion thereof described herein, the tubing set is assembled andsterilized originally in a first package and the ultrafilter or dialyzerand inlet line are assembled and sterilized originally in a secondpackage.

In a fifty-first aspect, which may be combined with any other aspect orportion thereof described herein, a medical fluid generation methodincludes purifying water; mixing the purified water to form a medicalfluid; filtering the medical fluid using at least one sterilesterilizing filter; and delivering the filtered medical fluid to aplurality of presterilized medical fluid containers in parallel, inseries or in parallel and series.

In a fifty-second aspect, which may be combined with any other aspect orportion thereof described herein, a method for preparing a medical fluidis provided comprising: providing a dual compartment syringe, whereinthe first compartment includes a first liquid concentrate and the secondcompartment includes a second liquid concentrate; providing a salinebag; injecting the first liquid concentrate and the second liquidconcentrate into the saline bag to form a mixture, the mixture being asuitable peritoneal dialysis fluid or a suitable CRRT solution forfeeding renal failure medical devices.

In a fifty-third aspect, which may be combined with any other aspect orportion thereof described herein, the dual compartment syringe comprisesa mixing nozzle configured to be connected to the saline bag to allowspiking the solutions with the first and second liquid concentrates, inparticular, the dual compartment syringe keeping the first and secondliquid concentrates separated during handling and allowing first andsecond liquid concentrates to mix together when injecting into thesaline bag.

In a fifty-fourth aspect, which may be combined with any other aspect orportion thereof described herein, the first liquid concentrate includesglucose, and/or the second liquid concentrate includes a buffer, such aslactate or bicarbonate, the mixture being a peritoneal dialysis fluid.Alternatively, the first liquid concentrate includes electrolytescomprising sodium, magnesium, calcium, and/or the second liquidconcentrate includes a buffer, such as lactate or bicarbonate, themixture being a CRRT solution.

In a fifty-fifth aspect, which may be combined with any other aspect orportion thereof described herein, volumes of the first and second liquidconcentrates are in a prefixed volume ratio in the dual compartmentsyringe and are pre-measured in the syringe based on a volume of thesaline bag into which the first and second liquid concentrates are to beinjected.

Additionally, any of the above aspects, or portions thereof, and/or anyof the features, functionality and alternatives described in connectionwith any one or more of FIGS. 1A to 4 may be combined with any of thefeatures, functionality and alternatives described in connection withany other of FIGS. 1A to 4 .

It is accordingly an advantage of the present disclosure to provide asystem that makes fresh dialysis fluid when time is available to do so,e.g., when one or more hemodialysis machine at a hospital or clinic isnot being used.

It is another advantage of the present disclosure to provide a systemthat makes fresh dialysis fluid for a hospital or clinic with minimalresource impact to the hospital or clinic.

It is a further advantage of the present disclosure to provide a systemthat makes fresh dialysis fluid at or near a hospital or clinic, e.g.,near where it will be used, and which is of a high quality.

It is yet a further advantage of the present disclosure to provide asystem that makes fresh dialysis fluid at or near a hospital or clinic,and which is placed in a container for later use.

Moreover, it is an advantage to make sterilized fluids, such as PDfluids, CRRT fluids, saline, lactated ringers and the like closer intime and distance to a point of use for the patient, which lessens theamount of supplies that have to be stored, e.g., at a patient's home.

It is still a further advantage to prepare PD fluid using one or morein-center hemodialysis machine.

Additional features and advantages are described in, and will beapparent from, the following Detailed Description and the Figures. Thefeatures and advantages described herein are not all-inclusive and, inparticular, many additional features and advantages will be apparent toone of ordinary skill in the art in view of the figures and description.Also, any particular embodiment does not have to have all of theadvantages listed herein and it is expressly contemplated to claimindividual advantageous embodiments separately. Moreover, it should benoted that the language used in the specification has been selectedprincipally for readability and instructional purposes, and not to limitthe scope of the inventive subject matter.

BRIEF DESCRIPTION OF THE FIGURES

FIGS. 1A to 1C are perspective views illustrating one system of thepresent disclosure for preparing and storing peritoneal dialysis (“PD”)fluid using an in-center dialysis machine.

FIG. 2 is a front view illustrating an alternative system of the presentdisclosure using an in-center dialysis machine to prepare and storeperitoneal dialysis (“PD”) fluid component solutions for later mixing toform a PD fluid or other sterilized fluid, such as CRRT fluids includingHD fluids and substitution or replacement fluids for HF and HDF, saline,lactated ringers and the like.

FIG. 3 is a top plan view of an alternative implementation of amulti-chamber container or bag of the present disclosure.

FIG. 4 is a front elevation view of an alternative embodiment for thesystems described herein using a reusable ultrafilter or dialyzer.

DETAILED DESCRIPTION

Referring now to the drawings and in particular to FIGS. 1A to 1C, anembodiment of a system 10 of the present disclosure, which uses adialysis machine 12, such as an in-center dialysis machine to createdialysis fluid for peritoneal dialysis (“PD”) is illustrated. FIGS. 1Ato 1C illustrate that system 10 may include a central water purificationstation or standalone water purifier 80 that feeds a plurality ofhemodialysis machines 12. Local water purification equipment may be usedinstead, such as any one or more of reverse osmosis (“RO”), ultraviolet(“UV”) radiation, electrodeionization, ultrafiltration, ion-exchangeresins, and/or heat disinfection. One suitable local water purifier hasthe product name WRO300H.

Hemodialysis machine 12 in FIGS. 1A to 1C includes at least one mixingpump for mixing purified water from central water purification stationor standalone water purifier 80 with at least one concentrate 62, 64.Hemodialysis machine 12 in one embodiment includes a purified water pumpthat pulls purified water from central water purification station orstandalone water purifier 80, such that central water purificationstation or standalone water purifier 80 may, but does not have to,supply its own water pressure. In an alternative embodiment, centralwater purification station or standalone water purifier 80 includes oneor more pump that pumps purified water under positive pressure tohemodialysis machine 12. Here, hemodialysis machine 12 does not have tohave a pump to pump purified water from central water purificationstation or standalone water purifier 80.

In any case, hemodialysis machine 12 includes pumps for mixing PD fluidand for delivering the dialysis fluid from the hemodialysis machine. Inone embodiment, hemodialysis machine 12 of system 10 includes a firstconcentrate pump for metering an electrolyte concentrate (possiblycontaining a buffer) from container 62 into the purified water and asecond concentrate pump for mixing glucose concentrate from a glucoseconcentrate container 64 with the mixture of purified water andelectrolyte concentrate. One or more conductivity cell (or other type ofcomposition sensor) is/are used in one embodiment to ensure the properproportioning of buffer concentrate 62 with purified water and themixture of buffer concentrate 62 and purified water with glucoseconcentrate 64. The conductivity readings may be temperaturecompensated. Hemodialysis machine 12 may also include a heater, such asan inline heater. The heater may (e.g., to promote mixing and/or forimproved conductivity readings) or may not be energized during thepreparation of the PD fluid for storage in containers or bags 90.Hemodialysis machine 12 also includes a pump, e.g., the fresh dialysisfluid pump of the machine, for delivering fresh (possibly heated) PDfluid at a desired or settable pressure and/or flowrate, e.g., 750 mm Hgor less and 300 to 800 mL/min, e.g., 500 mL/min. The pressure depends onthe length of the overall tubing leading to PD fluid containers 90,wherein the containers do not add significantly to the required pressureuntil becoming full. Sterile sterilizing grade filters 44 a, 44 b addsignificantly to pressure drop and are therefore sized and numbered soas to provide an overall pressure drop that is within the capability ofhemodialysis machine 12, e.g., 750 mm Hg or less.

It is contemplated for system 10 to mix purified water with the PDconcentrates in a plurality of ways. In the above example, buffer(electrolyte) concentrate 62 is mixed first with purified water and afirst conductivity reading is taken. That mixture is then mixed withglucose concentrate 64 and a final conductivity reading is taken. In analternative embodiment, glucose concentrate 64 is mixed first withpurified water and a first reading is taken via a glucose sensor, whichmay be a separate sensor coupled fluidly with hemodialysis machine 12 orintegrated into the internal flowpath of the hemodialysis machine. Thatmixture is then mixed with buffer concentrate 62 and a finalconductivity reading is taken. In a further alternative embodiment, themixing of at least one of buffer concentrate 62 or glucose concentrate64 is done on a volumetric basis, wherein precise amounts of at leastone concentrate 62 and 64 is/are mixed with a precise amount of purifiedwater.

It is contemplated to make hardware and software changes as needed to anexisting hemodialysis machine 12 of system 10 for the production of PDfluid. Software changes are made in a control unit 50 of dialysismachine 12. Control unit 50 as illustrated includes one or moreprocessor 52, one or more memory 54 and a video controller 56 forcontrolling user interface 58. The software changes may include, forexample, establishing a dedicated container filling mode in whichhemodialysis machine 12 runs at a specified pressure and flowrate for aknown amount of time or metered amount of volume of PD fluid. Thefilling mode in an embodiment allows for different sizes and numbers ofcontainers 90 to be filled, e.g., by prompting the operator to enter thesize of container 90, e.g., two, four, five or six liters, and to enterthe number of containers 90 to be filled in the filling sequence (onecontainer or multiple ganged containers). From there, hemodialysismachine 12 calculates how much PD fluid is to be prepared for the nextbatch or filling sequence and delivers same to a tubing set, whichincludes one or more container 90, any tubing and connectors connectingtwo or more containers 90, and in one embodiment one or more terminal orsterile sterilizing grade filters 44 a, 44 b provided upstream of thecontainers.

The software updates may also include a confirmation in the filling modefrom the operator that a filled one or more container 90 has beenremoved from hemodialysis machine 12 and that a new, empty andpresterilized tubing set including one or more container 90 and one ormore terminal or sterile sterilizing grade filters 44 a, 44 b have beenloaded onto the machine. The confirmation may also ask the operator toconfirm the number and volume of containers 90 of the new tubing set.Once confirmed, hemodialysis machine 12 in the filling mode enables theoperator to press “start” to begin the next filling sequence.

Software updates may also include any updates needed to cause a label tobe printed having any desired information, such as date that the PDfluid is prepared, time that the PD fluid is prepared, expiration periodor date, type or formulation of the PD fluid, quantity of the PD fluid,and machine identification that prepared the PD fluid, operatoridentification, and/or lot number. Hardware changes may again include alabel printer 14 provided with hemodialysis machine 12 as illustrated inFIGS. 1A to 1C. In an alternative embodiment, label printer 14 isprovided separately from hemodialysis machine 12. Hardware changes mayalso include the provision of a hanger or holder 16 positioned andarranged to hang or otherwise hold one or more container 90 of dialysisfluid. Hanger or holder 16 may for example be one or more safety clampprovided by hemodialysis machine 12.

Software updates may further include updates needed to control a remote,standalone valve station discussed in connection with FIG. 1C. Thestandalone valve station selectively opens and closes the filling linesleading to the PD fluid containers. Hemodialysis machine 12 may here beprogrammed to tell the standalone valve station which valves to open andwhen. Hemodialysis machine 12 is also programmed to coordinate PD fluiddelivery with the valve sequencing of the standalone valve station.

FIG. 1A illustrates that in one embodiment, multiple containers 90 arefilled with PD fluid in a single filling sequence. In the illustratedembodiment, containers 90 are provided as part of a large overallpresterilized tubing set 20. Any portion of tubing set may be formedfrom any one or more plastic, e.g., polyvinylchloride (“PVC”) or anon-PVC material, such as polyethylene (“PE”), polyurethane (“PU”) orpolycarbonate (“PC”). Tubing set 20 includes an inlet line 22 a havingan inlet line connector 22 b. Inlet line connector 22 b may beconfigured to connect to a dialysis fluid outlet port (not illustrated)of hemodialysis machine 12 or to a dialysis fluid outlet line (notillustrated) extending from hemodialysis machine 12. Inlet line 22 aconnects via a Y or T connection 24 to a pressure transmission line 26 ahaving a pressure transmission line connector 26 b. Pressuretransmission line connector 26 b plugs into a pressure transducer port18 of hemodialysis machine 12. Fluid pressure within pressuretransmission line 26 a is transmitted to a pressure transducer viapressure transducer port 18.

In one embodiment, control unit 50 looks at multiple pressure readingsover the course of a filling procedure to determine when containers 90have been filled to a desired level. Here, control unit 50 may take afirst pressure reading after an initial filling amount, e.g., 100 mL, ofdialysis fluid is delivered to containers 90. This reading may be takenby momentarily stopping the filling so that the pressure measured is astatic pressure. Then, filling is resumed and a second pressuremeasurement is taken immediately to record a corresponding dynamicpressure, which reflects the pressure drop caused by tubing set 20,including sterile sterilizing grade filters 44 a and 44 b. Control unit50 may then take multiple dynamic readings over time, that is, withoutstopping flow, to monitor how the pressure changes due a changing flowresistance provided by sterile sterilizing grade filters 44 a and 44 b.Control unit 50 then waits until a time when it is expected thatcontainers 90 are becoming close to being full based on a known flowrateand total volume of containers 90 and stops flow again to take anadditional static pressure reading via the pressure transducer. If achange in static pressure equals or exceeds a characteristic changeknown to control unit 50 to correspond to a container full condition,then the control unit stops the filling and notifies the operator thatcontainers 90 are full and ready to be removed. If a change in staticpressure does not meet a characteristic change known to control unit 50to correspond to a container full condition, then the control unitresumes filling either for a preset period of time, or for a calculatedperiod of time expected to meet or exceed the characteristic change instatic pressure. Control unit 50 stops flow again after the preset orcalculated amount of time to take an additional static pressure readingfrom the pressure transducer. Control unit 50 repeats the above loopuntil the change in static pressure equals or exceeds a characteristicchange.

The above structure and method for determining a container fullcondition operates so that the operator does not have to enter, andcontrol unit 50 does not have to know, the number and volume ofcontainers 90. The filling sequence is nevertheless stoppedautomatically so that the operator does not have to monitor visually ortime the filling of containers 90.

One or more final terminal or sterile sterilizing grade filters 44 a, 44b is/are located downstream of Y or T connection 24 as illustrated inFIGS. 1A to 1C. Terminal or sterile sterilizing grade filters 44 a, 44 bin combination with the purification provided by central waterpurification station or standalone water purifier 80 provide a purityfor the PD fluid suitable for delivery into the patient's peritonealcavity. One final terminal or sterile sterilizing grade filter 44 a or44 b may be sufficient to provide the necessary purity, however, two ormore of such filters provide redundancy in case one of the filtersbecomes compromised. In an embodiment, terminal or sterile sterilizinggrade filter 44 a or 44 b are sized and configured for the number ofcontainers 90 provided with tubing set 20. Pore sizes for the sterilesterilizing grade filters 44 a and 44 b may, for example, be less than amicron, such as 0.1 or 0.2 micron. Suitable sterile sterilizing gradefilters 44 a and 44 b may, for example, be Pall IV-5 filters, be Yukon3filters, or be filters provided by the assignee of the presentdisclosure.

Where two sterile sterilizing grade filters 44 a and 44 b are provided,e.g., in FIGS. 1A to 1C, system 10 likely does not need to perform anintegrity check due to the redundancy. For either system 10 or 110 (FIG.2 ), however, it is contemplated to test the integrity of a terminal orsterile sterilizing grade filter 44 a or 44 b, especially when only oneis provided (however the test may still be applied to two filters).System 10 or 110 wets the filter by driving PD fluid (system 10) orconcentrate solution (system 110) through and past the filter 44 aand/or 44 b. System 10 or 110 drives enough PD fluid or solution pastthe filter, so that after the air integrity test, the PD fluid orsolution can be pulled back to dialysis machine 12 to remove all airfrom the filter 44 a and/or 44 b to an air collection device or vent ofdialysis machine 12. Then, dialysis machine 12 operates the dialysisfluid pump to pump air in the line leading to filter 44 a and/or 44 buntil air reaches the filter, at which point the air cannot proceedthrough a wetted and intact filter. Control unit 50 then causes an airpressure to be built and monitored in the line leading to filter 44 aand/or 44 b. If the pressure holds, the filter is deemed to be intact.If a pressure decrease is sensed, control unit 50 deems the filter to becompromised and prompts the operator to discard the entire tubing set.When the filter (upstream filter if two are provided) is deemed to beintact, hemodialysis machine 12 using the dialysis fluid pump applies anegative pressure in the line leading to filter 44 a and/or 44 b,pulling the dialysis fluid (system 10) or concentrate solution (system110) residing downstream from the filter, back through the filter andthe line, pushing the air in an upstream direction to the air collectiondevice or vent of machine 12. Dialysis fluid filling may then proceed asdescribed herein, with the line leading to filter 44 a and/or 44 bprimed with PD fluid or concentrate solution.

As illustrated in FIG. 1A, it is contemplated for overall tubing set 20to include treatment tubing sets 30, which are eventually separated fromeach other, each set 30 located downstream from terminal or sterilesterilizing grade filters 44 a, 44 b and each including a container 90and an overpouch 32 housing PD patient tubing 34. In an alternativeembodiment, overpouch 32 additionally covers container 90. PD patienttubing 34 may be configured for manual or Continuous AmbulatoryPeritoneal Dialysis (“CAPD”) or for operation with a peritoneal dialysiscycler for automated peritoneal dialysis (“APD”) or for other sterilizedfluid applications, such CRRT treatments and saline or NaCl fluiddeliveries. In an embodiment, overall tubing set 20 is presterilized(e.g., via gamma radiation, ethylene oxide or steam) with treatmenttubing sets 30 ganged via filling tubes 36 as illustrated in FIG. 1A.

FIG. 1A illustrates that filling tubes 36, a manifold connector 38 andconnecting ports 90 p provided on containers 90 enable the containers tobe ganged in series, in parallel or in both series and parallel. Whiletwo columns of four containers 90 are illustrated in FIG. 1A, it iscontemplated to instead provide three or more columns of containers. Asdiscussed herein, the series and/or parallel filling of containers 90may be performed via control unit 50 (i) causing hemodialysis machine 12to meter an amount of fresh PD fluid based on the number and volume ofcontainers 90 or (ii) detecting a characteristic static pressure change(discussed above) indicating that each of the containers 90 has beenfilled.

Depending on the number of containers 90 provided with overall tubingset 20, it is contemplated to hang or otherwise place containers 90(perhaps only a single container) on a hanger, infusion fluid pole orother type of holder 16 of hemodialysis machine 12. Alternatively,overall tubing set 20 may be supported by a rack (not illustrated)located adjacent to hemodialysis machine 12. Hemodialysis machine 12and/or the rack may then be provided with a heat sealer or tube welder(illustrated in FIG. 2 ) for heat sealing filling tubes 36 leading tocontainer ports 90 p closed. Once the filling tubes 36 are heat sealedclosed, the filling tubes 36 may be cut with scissors or perhapsseparated by the heat sealing, allowing tubing sets 30 with their filledcontainers to be separated from one another. Filling tubes 36 leading tocontainer ports 90 p may alternatively be mechanically clamped, cut andcapped for sterile separation from each other.

FIG. 1B illustrates that overall tubing set 20 of system 10 may furtherinclude a return line 40 a and return line connector 40 b for allowingPD fluid samples to be returned to hemodialysis machine 12 for testing.In the illustrated embodiment, return line 40 a may have one or moreterminal or sterile sterilizing grade filters 44 a or 44 b, whichprevent(s) any backflow in return line 40 a from potentiallycontaminating the PD fluid contained within containers 90. The testingof the fluid at hemodialysis machine 12 may involve any desired form oftesting, e.g., any one or more of further conductivity testing, sampleremoval for microbial, e.g., colony forming unit (“CFU”), testing orchlorine testing.

In particular, one suitable hemodialysis machine for system 10 is an AK98™ hemodialysis machine produced by the assignee of the presentdisclosure, which provides a conductivity sensor positioned in a useddialysis fluid path leading to drain. That conductivity sensor may beused to ensure that the PD fluid samples have the same (or within anallowed margin of error) conductivity as an expected conductivity. Inone embodiment, return line 40 a is connected to a dialyzer outlet lineof hemodialysis machine 12, wherein the dialyzer outlet line is thereusable tubing provided with hemodialysis machine 12 that is normallyconnected to an outlet of the dialyzer (for a hemodialysis treatment).The operator then commands hemodialysis machine 12 to suck a sample fromcontainers 90 via return line 40 a and send the sample past theconductivity sensor to perform a test measuring the conductivity of thesample. In an embodiment, the sensed conductivity is displayed byhemodialysis machine 12 for the operator to view and either confirm thebatch of filled PD fluid containers 90 if the reading is good or discardthe batch if the reading is outside of acceptable limits. In anotherembodiment, hemodialysis machine 12 is programmed to alarm if the sensedconductivity is outside of the acceptable limits. Otherwise, the filledcontainers may be assumed to be acceptable.

Assuming the test sample volume to be small, e.g., 100 mL or less, thetime needed for hemodialysis machine 12 to transport the sample to theconductivity sensor will be short. Here, there is a very low risk thatbacteria may enter the system via the return line 40 a and thus one ormore terminal or sterile sterilizing grade filter 44 a or 44 b in FIG.1B may not be needed. Nevertheless, it may be desirable as an extrasafety precaution to provide such one or more filter as illustrated inFIG. 1B.

If hemodialysis machine 12 is not equipped with a conductivity sensorthat is accessible, system 10 may instead use an external conductivitysensor and alarm and/or readout. PD fluid system 10 may also include anexternal glucose sensor to confirm the glucose level of filled PD fluidcontainers 90.

FIG. 1C illustrates that system 10 may further include or provide astandalone valve station 70, e.g., removeably fixed to the rack holdingoverall tubing set 20. Valve station 70 includes valves 72 a to 72 d,e.g., a valve for each filling tube 36. While four valves areillustrated, any number of valves may be provided depending on thenumber of filling lines to be opened and closed. Valves 72 a to 72 d inan embodiment are electrically opened, de-energized closed solenoidpinch valves. Valve station 70 in an embodiment includes power equipment(not illustrated) for supplying power to valves 72 a to 72 d. Valvestation 70 may also include a small microcontroller (not illustrated)for controlling when power is supplied to which valves 72 a to 72 d. Inan embodiment, the microcontroller includes a transceiver that operateswirelessly, e.g., via Bluetooth or WiFi, with a transceiver associatedwith control unit 50 of hemodialysis machine 12 (or could operate in awired manner, e.g., via Ethernet). In such an embodiment, control unit50 of hemodialysis machine 12 commands microcontroller 254 of valvestation 70 to sequence valves 72 a to 72 d in a desired manner. Forinstance, control unit 50 of hemodialysis machine 12 commands themicrocontroller to sequence valves 72 a to 72 d such that the front rowof containers 90 is filled first, followed by the second row, then thethird row, then the bottom row. The completion of the filling of eachrow may be via a known amount of PD fluid delivered based on number andvolume of containers 90 in each row or via a sensed characteristicstatic pressure change as discussed herein.

Control unit 50 is in one embodiment programmed to control the mixing ofconcentrates and purified water at the same time as controlling valves72 a to 72 d of valve station 70 so as to allow different containers 90in tubing set 20 to be filled with different formulations or fluids ofdifferent chemical constituencies. With PD, for example, control unit 50may be programmed to produce different glucose concentrations indifferent containers 90. Here, system 10 may create a set of containers90 that hold different fluids that are, for example, individualized fora specific patient according to the patient's prescription. Control unit50 of hemodialysis machine 12 is programmed to create the prescribed setof filled containers 90 for the patient. In one PD example, system 10fills three PD containers 90 with a low glucose PD fluid (by openingvalves 72 a to 72 c one at a time for the three containers) and a fourthPD container with a higher glucose level fluid (by opening valve 72 d),wherein the patient's prescription calls for all four containers to beused in a single treatment, for example, the three low glucosecontainers used first followed by the higher glucose container as a lasttreatment fill.

In an alternative embodiment, if only two valves are needed, two clampsprovided on the outside of hemodialysis machine 12 may be used instead(see, e.g., clamps 74 and 76 of FIG. 2 ). The dialysis machine clampsare programmably opened and closed via control unit 50. Here, manifoldconnector 38 splits into two filling tubes 36, each of which isselectively opened and closed via one of the automated machine clamps.

It is also contemplated for the transceiver operable with control unit50 of mixing device or hemodialysis machine 12 in either system 10 or110 (FIG. 2 ) to communicate wired or wirelessly via a network with aninventory tracking system that logs the number, time and date of freshdialysis fluid containers 90 prepared and the raw materials consumed.The inventory tracking system may be accessed to know how manycontainers 90 having differing expiration dates have been produced andat what location, e.g., hospital or clinic. The inventory trackingsystem may also identify raw materials that need to be ordered anddelivered and in one embodiment places such orders automatically.

Referring now to FIG. 2 , an alternative embodiment of a system 110 ofthe present disclosure, which uses an in-center dialysis machine tocreate PD dialysis fluid component solutions for a final PD fluid isillustrated. The primary difference with system 110 is that a final PDfluid is not created, instead PD fluid concentrate component solutionsare created and stored in containers for final mixing at the time ofuse. FIG. 2 illustrates that system 110, like system 10, may include acentral water purification station or standalone water purifier 80 thatfeeds a plurality of hemodialysis machines 12 (local water purificationequipment described for system 10 may be used in system 110alternatively). Hemodialysis machine 12 in FIG. 2 includes all of thestructure and functionality discussed above for mobile systems 10. Inparticular, hemodialysis machine 12 includes at least one mixing pumpfor mixing purified water from central water purification station orstandalone water purifier or standalone water purifier 80 with at leastone concentrate 62, 64. Hemodialysis machine 12 in one embodimentincludes a purified water pump that pulls purified water from centralwater purification station or standalone water purifier 80, such thatcentral water purification station or standalone water purifier 80 may,but does not have to, supply its own water pressure. In an alternativeembodiment, central water purification station or standalone waterpurifier 80 includes one or more pump that pumps purified water underpositive pressure to hemodialysis machine 12. Here, hemodialysis machine12 does not have to have a pump to pump purified water from centralwater purification station or standalone water purifier 80.

In any case, hemodialysis machine 12 includes pumps for mixing PD fluidand for delivering the dialysis fluid from the hemodialysis machine. Inone embodiment, hemodialysis machine 12 of system 110 includes a firstconcentrate pump for metering buffer (or electrolyte) concentrate from abuffer concentrate container 62 into the purified water and a secondconcentrate pump for mixing glucose concentrate from a glucoseconcentrate container 64 into the purified water. One or moreconductivity cell is/are used in one embodiment to ensure the properproportioning of buffer concentrate 62 with purified water and theproportioning of glucose concentrate 64 with purified water. Theconductivity readings may be temperature compensated. Hemodialysismachine 12 may also include a heater, such as an inline heater. Theheater may (e.g., to promote mixing and/or for improved conductivityreadings) or may not be energized during the preparation of the PD fluidconcentrates for storage in alternative dual chamber containers or bags190.

Hemodialysis machine 12 also includes a pump, e.g., the fresh dialysisfluid pump of the machine, for delivering the fresh (possibly heated) PDfluid component solutions at a desired or settable pressure and/orflowrate, e.g., the same as system 10, or 750 mm Hg or less and 300 to800 mL/min, e.g., 500 mL/min. The pressure depends on the length of theoverall tubing leading to containers 190, wherein the containers do notadd significantly to the required pressure until becoming full. One ormore sterile sterilizing grade filters 44 a, 44 b add significantly topressure drop and is/are therefore sized and numbered so as to providean overall pressure drop that is within the capability of hemodialysismachine 12, e.g., 750 mm Hg or less.

System 110 is provided with two or more concentrates, labeled generallyas C1 and C2. Concentrates C1 and C2 may be concentrates for producingany type of sterilized medical fluid discussed herein, such as PD fluid,any type of continuous renal replacement treatment (“CRRT”) fluidincluding HD fluids, substitution or replacement fluids forhemofiltration (“HF”) and hemodiafiltration (“HDF”), saline, lactatedringers and other NaCl solutions. For ease of description, system 110 isdescribed for PD fluids, wherein Concentrate C1 is a buffer concentrateand concentrate C2 is a glucose concentrate.

System 110 is provided with an alternative large overall tubing set 120,which includes alternative containers 190. Any portion of tubing set 120may be formed from any one or more plastic, e.g., polyvinylchloride(“PVC”) or a non-PVC material, such as polyethylene (“PE”), polyurethane(“PU”) or polycarbonate (“PC”). Tubing set 120 includes two manifolds122 a and 122 b, one each for the solutions formed from concentrates 62and 64. A C1-concentrate manifold line 124 carries a combination ofC1-concentrate (buffer) and purified water from hemodialysis machine 12to manifold 122 a. A C2-concentrate manifold line 126 carries acombination of C2-concentrate (glucose) and purified water fromhemodialysis machine 12 to manifold 122 b. C1-concentrate manifold line124 and C2-concentrate manifold line 126 may be connected via Y orT-connectors 132 a and 132 b as illustrated, e.g., for priming purposes,and to flush reusable supply line 46, after having filled firstcompartment 192 with a first concentrate solution, with a secondconcentrate solution that is later filled into second compartment 194.The flush is performed to drain via drain line 48.

Manifold lines 124 and 126 and their respective concentrates arecontrolled independently via outer automated machine clamps 74 and 76,respectively, wherein the automated machine clamps 74 and 76 are undercontrol of control unit 50 having one or more processor 52, one or morememory 54 and a video controller 56 for controlling user interface 58.

Manifold lines 124 and 126 of disposable set 120 in the illustratedembodiment connect via Y-connector 132 a and disposable supply line 136to reusable supply line 46 of hemodialysis machine 12 having a reusableconnector, where supply line 46 may be the reusable fresh dialysis fluidline normally connected to a dialyzer for treatment. A disposable drainline 138 connects to a reusable connector of reusable drain line 48 ofmachine 12, where drain line 48 may be a reusable used dialysis fluidline normally connected to the dialyzer. After the filling ofalternative containers 190 and the removal of disposable set 120 fromreusable lines 46 and 48, the reusable connectors of reusable lines 46and 48 may be plugged into dedicated docking stations of hemodialysismachine 12 or be connected together, after which a short disinfectioncycle, e.g., via heated purified water, may be performed while a nextdisposable set 120 is installed for a next fill.

Fill lines 128 a to 128 d lead from manifold 122 a to a C1-concentratesolution chamber 192 of each of dual chamber containers or bags 190.While four fill lines 128 a to 128 d are illustrated, any desired numberof fill lines 128 n may be provided alternatively. Fill lines 130 a to130 d lead from manifold 122 b to a C2-concentrate solution chamber 194of each of dual chamber containers or bags 190. Again, while four filllines 130 a to 130 d are illustrated, any desired number of fill lines130 n may be provided alternatively, wherein 130n equals 128n.

In any desired order, hemodialysis machine 12 of system 110 undercontrol of control unit 50 mixes C1-concentrate (buffer) fromC1-concentrate source 62 with purified water in a desired ratio anddelivers a desired amount of the solution to the C1-concentrate solutionchamber 192 of each of dual chamber container or bag 190. Hemodialysismachine 12 of system 110 under control of control unit 50 mixesC2-concentrate (glucose) from C2-concentrate source 64 in a desiredratio and delivers a desired amount of the solution to theC2-concentrate solution chamber 194 of each of dual chamber container orbag 190. Chambers 192 and 194 in one embodiment are separated by afrangible seal 196, which a nurse, clinician or patient opens at thetime of use to allow the C1-concentrate solution and the C2-concentratesolution to mix together to form an overall PD fluid for treatment. Thevolume of the finally mixed PD fluid is any desired amount, e.g., two,four, five or six liters.

It should be appreciated that system 110 is fully capable of pumping twoconcentrate solutions into a single chamber 192 or 194, which may forexample be mixed with purified water. So, for example, threeconcentrates may be provided to produce any medical fluid discussedherein, wherein a first concentrate solution formed from the firstconcentrate is delivered to chamber 192, while second and thirdconcentrate solutions formed from the second and third concentrates,respectively, are delivered to chamber 194.

The volumes of the C1-concentrate solution and the C2-concentratesolution delivered to chambers 192 and 194, respectively, need to berelatively precise. It is accordingly contemplated to use an accuratedialysis fluid pump of hemodialysis machine 12, e.g., a piston pump, ora less accurate dialysis fluid pump, e.g., a gear pump, in combinationwith one or more flowmeter outputting to control unit 50. Here, controlunit 50 is programmed to pump the needed volumes of C1-concentrate(buffer) solution and the C2-concentrate (glucose) solution and to stoppumping and close clamps 74 and 76 when the programmed volumes arereached. Alternatively, an optional weigh scale 140 may be provided toweigh containers or bags 190 as they hang from a multi-unit hanger orholder 142. Weigh scale 140 outputs wired or wirelessly to control unit50, which is programmed to stop pumping and close clamps 74 and 76 whenthe programmed C1-concentrate or buffer solution weight and theC2-concentrate or glucose solution weight are reached.

Chambers 192 and 194 are sized to contain a volume of a particularconcentrate solution, such that when the concentrate solutions are mixedafter frangible seal 196 is ruptured, the resulting overall medicalfluid has and meets a defined concentration for one or more chemicalconstituent. In a PD example, a 1.36% glucose ready to use PD fluid mayhave a sodium chloride concentration of 5.38 g/L and an equivalent toanhydrous glucose concentration of 13.6 g/L. Chambers 192 and 194 arethen sized to hold a volume and concentration of buffer and glucosesolutions that when mixed meet the above concentrations. In one example,to create one liter of 1.36% glucose ready to use PD fluid having theabove final concentrations, chamber 192 is sized to hold 637.5 ml of abuffer solution having a sodium chloride concentration of 8.43 g/L,while chamber 194 is sized to hold 362.5 ml of a glucose solution havingan equivalent to anhydrous glucose concentration of 37.5 g/L. Here,control unit 50 is programmed to create such buffer and glucosesolutions by adding purified water to concentrates C1 and C2,respectively, and to deliver the specified volumes of the solutions tocompartments 192 and 194.

System 110 of FIG. 2 also illustrates structure and functionality forseparating any of the containers or bags 90 or 190 discussed herein fromthe remainder of a disposable set, here disposable set 120. In FIGS. 1Ato 1C, the structure and functionality described here could be used toseparate containers or bags 90 from overall tubing or disposable set 20.The structure includes a handheld heat sealer 150, which may for examplebe a Sebra® 1105 Heat Sealer, which seals closed both fill lines 128 ato 128 d and fill lines 130 a to 130 d. If needed, each fill line may besealed two or more times for extra security. After sealing, each of filllines 128 a to 128 d and 130 a to 130 d may be clamped below the heatseal(s) to prevent spillage, e.g., via a Roberts™ clamp, and then cutvia scissors 152 between heat seal(s) and the clamps or between heatseals. One possible solution to avoid mechanical clamps is to make threeheat seal welds and to cut between the second and third welds countingfrom container 90 or 190. The first and second welds remain forincreased security.

The separated containers or bags 190 may then be labeled via a labelprinted at label printer 14 of hemodialysis machine 12 or via a separatelabel printer, wherein the label may include any of the informationdiscussed herein. Once separated containers or bags 190 are labeled,they may be loaded onto a cart 154 and, for example, transported to apackaging area where the containers are packaged for delivery to a PDpatient's home for treatment or use at a hospital or clinic.

The dual chamber containers or bags 190 having separate C1- and C2-PDconcentrate solutions have a potentially longer shelf life thancontainers or bags 90 holding a finally mixed PD fluid, which may be amonth or longer. The finally mixed fluid may precipitate over time,leading to a shorter shelf life. Containers or bags 190 promote thepossibility of using bicarbonate, or a mixture of bicarbonate andlactate, as a buffer concentrate. It is also contemplated to placecontainer of bag 190 in an overpouch, which helps to prevent degradationof the two or more separated solutions.

There are a number of alternative embodiments for tubing set 120. In afirst alternative embodiment, at least one sterile sterilizing gradefilter 44 a, 44 b is moved so that a first at least one sterilesterilizing grade filter 44 a, 44 b is located in any desired locationalong manifold line 124 and a second at least one sterile sterilizinggrade filter 44 a, 44 b is located in any desired location alongmanifold line 126. In a second alternative embodiment, Y or T-connector132 b is moved upstream of sterile sterilizing grade filter 44 a, 44 b,so that any contamination formed via the connection of disposable drainline 138 to reusable drain line 48 is removed via downstream sterilesterilizing grade filter 44 a, 44 b. It should be appreciated that forany version of tubing set 120 discussed herein, a clamp or valve locatedinside hemodialysis machine 12 and under control of control unit 50opens or occludes reusable drain line 48 to allow or not allow fluid toflow back down disposable drain line 138 via Y or T-connector 132 b.

Referring now to FIG. 3 , an alternative multi-chamber container 190 foruse with system 110 is illustrated, and which may be made of any of thematerials discussed herein. Alternative multi-chamber container 190includes chambers 192 and 194 for receiving C1-concentrate solution andC2-concentrate solution, respectively, as has been described herein.Alternative multi-chamber container 190 includes at least one additionalchamber 198, wherein all three chambers 192, 194 and 198 are separatedby frangible seal 196. Fill line 128 a feeds C1-concentrate solution tochamber 192, while fill line 128 b feeds C2-concentrate solution tochamber 194 as has been discussed herein.

It is contemplated for system 110 to use at least one additional chamber198 in a plurality of ways, each under control of control unit 50. Inthe illustrated embodiment, a third fill line 134 a is placed in fluidcommunication with at least one additional chamber 198 so thathemodialysis machine 12 is able to fill chamber with a thirdC3-concentrate solution. If hemodialysis machine 12 includes only twoexternal clamps 74 and 76, then standalone valve station 70 described inconnection with FIG. 1C may be employed to control third fill line 134 aor all three fill lines 128 a, 130 a and 134 a. The proportioning andvolumetric control of a third C3-concentrate solution to additionalchamber 198 may be performed via any of the structures and methodsdescribed herein.

Additional chamber 198 may for example hold a second glucose solution,which is mixed with the first glucose solution from chamber 194 andbuffer solution from chamber 192 to form a ready to use PD fluid whenfrangible seal 196 is ruptured. Additional chamber 198 may also be usedto receive an additional solution for mixing to form any type ofcontinuous renal replacement treatment (“CRRT”) fluid including HDfluids, substitution fluids for hemofiltration (“HF”) andhemodiafiltration (“HDF”), saline, lactated ringers and other NaClsolutions.

Three chamber container 190 may accordingly operate with a thirdC3-concentrate or with only two concentrates C1 and C2, wherein a firstone of the concentrates is proportioned differently with purified waterto produce different solutions of the one concentrate for filling two ofthe three chambers. The second concentrate is then proportioned toproduce a desired second concentrate solution for filling the thirdchamber.

In an alternative embodiment, additional chamber 198 is prefilled with adesired solution and sterilized along with overall tubing set 120. Here,third fill line 134 a is not needed. In the PD fluid example above,additional chamber 198 may be prefilled with a second glucose solution,which is mixed with the first glucose solution from chamber 194 andbuffer solution from chamber 192 to form a ready to use PD fluid whenfrangible seal 196 is ruptured. Additional prefilled and presterilizedchamber 198 may also be used to hold an additional solution for mixingto form any type of continuous renal replacement treatment (“CRRT”)fluid including HD fluids, substitution fluids for hemofiltration (“HF”)and hemodiafiltration (“HDF”), saline, lactated ringers and other NaClsolutions.

Container 190 in FIG. 3 includes an outlet port 190 o for allowing thefinally mixed fluid to be fluidly communicated for treatment.

Referring now to FIG. 4 , an alternative implementation for systems 10and 110 is illustrated. Systems 10 and 110 provide presterilized tubingsets 20 and 120, respectively, as discussed herein and rely on one ormore sterile, sterilization filters 44 a and 44 b to place the medicalfluids (system 10) or component solutions (system 110) in a sterilizedcondition for patient use. FIG. 4 adds a reusable filter 82, which maybe an ultrafilter or a dialyzer, which in one embodiment is mounted tohemodialysis machine 12. In the illustrated embodiment, reusable filter82 is an ultrafilter having an inlet port 82 a that receives medicalfluids or component solutions from hemodialysis machine 12, and a rejectport to which a short, e.g., less than twelve inches (30.5 cm), primingline 84 is connected to allow reusable filter 82 to be primed afterwhich priming line 84 is clamped closed via mechanical clamp 86.Ultrafilter 82 also includes an outlet port 82 b that outputs furtherpurified medical fluids or component solutions to presterilized tubingsets 20 and 120, respectively.

FIG. 4 illustrates how reusable filter 82 interacts differently withsystems 10 and 110. In system 10, inlet line connector 22 b of tubingset 20 instead of connecting to an outlet port or reusable supply lineof hemodialysis machine 12, as discussed in connection with FIGS. 1A to1C, connects here to the outlet port of reusable filter 82. Tubing set20 may still provide one or more a sterile sterilizing grade filters 44a, 44 b (shown optionally in phantom line), which further sterilize themedical fluid and protect against any contamination formed due to theconnection of connector 22 b to reusable filter 82. Further sterilizedfluid exiting one or more sterile sterilizing grade filters 44 a, 44 bflows via to manifold connector 38 and filling tubes 36 to containers orbags 90 as described herein.

In system 110, disposable line 136 of tubing set 120 instead ofconnecting to a reusable supply line 46 of hemodialysis machine 12, asillustrated in FIG. 2 , connects here to the outlet port of reusablefilter 82. Reusable supply line 46 in FIG. 4 connects instead to theinlet port of reusable filter 82. Tubing set 120 may still provide oneor more a sterile sterilizing grade filters 44 a, 44 b (shown optionallyin phantom line), which further sterilize the medical fluid and protectagainst any contamination formed due to the connection of disposableline 136 to reusable filter 82. In FIG. 4 , disposable drain line 138still connects to reusable drain line 48 as illustrated in FIG. 2 .Further sterilized fluid exiting one or more sterile sterilizing gradefilters 44 a, 44 b flows via Y or T-connectors 132 a and 132 b, manifoldlines 124 and 126, and fill lines 128 a to 128 n and 130 a to 130 n tocontainers or bags 190 as described herein.

FIG. 4 illustrates that alternative or additional reusable filtrationmay be added to the presterilized tubing sets 20 and 120 of systems 10and 110, respectively. It is also expressly contemplated to packageultrafilter or dialyzer 82, reusable supply line 46 and priming line 84assembled and sterilized in a first package and to package either tubingset 20 including all of its structure discussed herein assembled andsterilized in a second package or tubing set 120 including all of itsstructure discussed herein assembled and sterilized in the secondpackage.

It is also contemplated to alternatively provide prefilled buffer andglucose chambers for PD systems 10 and 110 and to instead supplysterilized or purified water to an initially empty, e.g., the largestchamber. When the one or more frangible seal is broken, the concentratesmix with the sterilized or purified water to form PD fluid. Here, (i)the amount and concentration of the one or more concentrate and (ii) theamount and formulation of the dialysis fluid or the amount of sterilizedor purified water are selected to provide a desired volume and overallformulation of PD fluid. Providing separate prefilled and sterilizedconcentrate chambers may again be desirable, for example, to increaseshelf life of a filled container 90.

It should be understood that various changes and modifications to thepresently preferred embodiments described herein will be apparent tothose skilled in the art. It is therefore intended that such changes andmodifications be covered by the appended claims.

1-42. (canceled) 43: A medical fluid generation system comprising: waterpurification equipment configured to provide purified water; a containerincluding a first chamber and a second chamber; a first concentrate; asecond concentrate; and a hemodialysis machine in fluid communicationwith the water purification equipment, the hemodialysis machineincluding: a mixing pump for mixing the first concentrate and the secondconcentrate with the purified water to form a first solution and asecond solution, a dialysis fluid pump for delivering the first solutionand the second solution, and a control unit configured to control themixing pump to form the first solution and the second solution and thedialysis fluid pump to deliver the first solution to the first chamberof the container and the second solution to the second chamber of thecontainer. 44: The medical fluid generation system of claim 43, whereinthe medical fluid generation system is a peritoneal dialysis fluidgeneration system, and wherein the first concentrate is a bufferconcentrate and the second concentrate is a glucose concentrate. 45: Themedical fluid generation system of claim 43, wherein the container is afirst container and wherein the medical fluid generation system includesa second container having a first chamber and a second chamber, andwherein the control unit is configured to deliver the first solution tothe first chamber of the first container and the second container andthe second solution to the second chamber of the first container and thesecond container. 46: The medical fluid generation system of claim 43,wherein the container is provided as part of a tubing set, wherein thetubing set includes a first filling line leading to the first chamber ofthe container and a second filling line leading to the second chamber ofthe container, and wherein the tubing set further includes a filterlocated upstream and/or downstream of both the first filling line andthe second filling line. 47: The medical fluid generation system ofclaim 46, wherein the tubing set includes (i) a first manifold line influid communication with a plurality of first filling lines leading tothe first chambers of a plurality of the containers and (ii) a secondmanifold line in fluid communication with a plurality of second fillinglines leading to the second chambers of the plurality of the containers.48: The medical fluid generation system of claim 43, wherein the firstchamber and the second chamber of the container are separated by atleast one frangible seal, the at least one frangible seal openable toallow the first solution to mix with the second solution. 49: Themedical fluid generation system of claim 43, further comprising a filterlocated upstream from the container, the filter configured to furtherpurify the first solution and the second solution for delivery, aftermixing, to a target, wherein the target is a patient's peritoneal cavityor an extracorporeal blood treatment apparatus. 50: The medical fluidgeneration system of claim 43, wherein the container includes a thirdchamber prefilled with a third solution either different than the firstsolution and the second solution or made from one of the firstconcentrate or second concentrate. 51: The medical fluid generationsystem of claim 43, wherein the container includes a third chamber, andwherein the control unit is further configured to control the mixingpump to form a third solution from a third concentrate and wherein thecontrol unit is further configured to control the dialysis fluid pump todeliver the third solution to the third chamber of the container. 52:The medical fluid generation system of claim 43, wherein the containerincludes a third chamber, and wherein the control unit is furtherconfigured to control the mixing pump to form a third solution from oneof the first concentrate or second concentrate and wherein the controlunit is further configured to control the dialysis fluid pump to deliverthe third solution to the third chamber of the container. 53: Themedical fluid generation system of claim 43, wherein the hemodialysismachine includes at least one of (i) a conductivity sensor and (ii) aglucose sensor outputting to the control unit as feedback to form themedical fluid, wherein the medical fluid is a peritoneal dialysis fluid.54: The medical fluid generation system of claim 43, wherein the waterpurification equipment includes a central water purification stationconfigured to feed a plurality of hemodialysis machines or a standalonewater purifier configured to feed the hemodialysis machine. 55: Themedical fluid generation system of claim 43, wherein the control unit isconfigured to enable an operator to enter at least one of (i) a volumeof medical fluid per container, (ii) a first volume for the firstchamber and a second volume for the second chamber, and (ii) a number ofcontainers to be filled with medical fluid. 56: The medical fluidgeneration system of claim 43, further comprising a filter located in atubing set upstream from the container, the filter configured to furtherpurify the medical fluid for delivery to a target, wherein the controlunit is configured to perform a pressure integrity test on the filter.57: The medical fluid generation system of claim 43, further comprisinga pressure transmission line in fluid communication with the container,the pressure transmission line configured to transmit a medical fluidpressure to a pressure transducer of the hemodialysis machine, thecontrol unit configured to look for a characteristic change in medicalfluid pressure to stop the dialysis fluid pump from delivering themedical fluid to the container. 58: The medical fluid generation systemof claim 57, wherein the pressure transmission line is a first pressuretransmission line in fluid communication with the first chamber of thecontainer and/or wherein the medical fluid generation system furthercomprises a second pressure transmission line in fluid communicationwith the second chamber of the container, the first pressuretransmission line and the second pressure transmission line configuredto respectively transmit a first solution medical fluid pressure and/ora second solution medical fluid pressure to the pressure transducer ofthe hemodialysis machine, the control unit configured to look for acharacteristic change in the first solution medical fluid pressureand/or second medical fluid pressure to stop the dialysis fluid pumpfrom delivering the first solution and/or the second solution to thecontainer. 59: The medical fluid generation system of claim 43, furthercomprising a return line from the container to the hemodialysis machinefor testing the medical fluid, and wherein the testing includes at leastcomposition or sterility testing. 60: The medical fluid generationsystem of claim 59, wherein the return line is a first return line fromthe first chamber of the container and/or wherein the medical fluidgeneration system further comprises a second return line from the secondchamber of the container to the hemodialysis machine for respectivelytesting the first solution and/or the second solution, and wherein thetesting includes at least composition or sterility testing. 61: Themedical fluid generation system of claim 43, wherein the system includesone or more heat sealers for sealing closed a first filling line leadingto the first chamber of the container and/or a second filling lineleading to the second chamber of the container. 62: The medical fluidgeneration system of claim 43, wherein the purified water is sterilizedwater, the first concentrate is a liquid concentrate including a bufferand sodium and magnesium electrolytes, the second concentrate being adry concentrate including glucose. 63: A medical fluid generation systemcomprising: water purification equipment configured to provide purifiedwater; a container including a first chamber and a second chamber; ahemodialysis machine in fluid communication with the water purificationequipment, the hemodialysis machine including a dialysis fluid pump fordelivering the purified water to the first chamber of the container;wherein the second chamber includes a concentrate for the medical fluid.64: The medical fluid generation system of claim 63, wherein the firstchamber and the second chamber are separated by at least one frangibleseal openable to allow the purified water to mix with the concentrate.65: The medical fluid generation system of claim 63, wherein thepurified water mixed with the concentrate forms peritoneal dialysisfluid. 66: The medical fluid generation system of claim 63, furthercomprising a first concentrate and wherein the hemodialysis machineincludes a mixing pump for mixing purified water with the firstconcentrate to form the concentrate for the second chamber, theconcentrate for the second chamber being a liquid concentrate. 67: Themedical fluid generation system of claim 63, wherein the second chamberincludes a prefilled concentrate for the medical fluid. 68: A medicalfluid generation system to produce peritoneal dialysis fluid comprising:water purification equipment configured to provide purified water; apresterilized tubing set including a container for storing peritonealdialysis fluid; a glucose or buffer concentrate; and a hemodialysismachine in fluid communication with the water purification equipment,the hemodialysis machine including a mixing pump for mixing the glucoseor buffer concentrate with the purified water to form peritonealdialysis fluid, a dialysis fluid pump for delivering the peritonealdialysis fluid to the container, and a control unit configured tocontrol the mixing pump to form the peritoneal dialysis fluid and thedialysis fluid pump to deliver the peritoneal dialysis fluid to thecontainer. 69: The medical dialysis fluid generation system of claim 68,wherein the hemodialysis machine includes at least one of (i) aconductivity sensor and (ii) a glucose sensor outputting to the controlunit as feedback to form the peritoneal dialysis fluid. 70: The medicaldialysis fluid generation system of claim 68, wherein the waterpurification equipment includes a central water purification stationconfigured to feed a plurality of hemodialysis machines or a standalonewater purifier configured to feed the hemodialysis machine. 71: Themedical dialysis fluid generation system of claim 68, wherein thecontrol unit is configured to enable an operator to enter at least oneof (i) a volume of peritoneal dialysis fluid per container or (ii) anumber of containers to be filled with peritoneal dialysis fluid. 72:The medical dialysis fluid generation system of claim 68, which includesa filter located in the presterilized tubing set upstream from thecontainer, the filter configured to further purify the peritonealdialysis fluid for delivery to a patient's peritoneal cavity, whereinthe control unit is configured to perform a pressure integrity test onthe filter. 73: The medical dialysis fluid generation system of claim68, further comprising a pressure transmission line in fluidcommunication with the container, the pressure transmission lineconfigured to transmit a peritoneal dialysis fluid pressure to apressure transducer of the hemodialysis machine, the control unitconfigured to look for a characteristic change in the peritonealdialysis fluid pressure to stop the dialysis fluid pump from deliveringthe peritoneal dialysis fluid to the container. 74: The medical dialysisfluid generation system of claim 68, wherein the container is a firstcontainer, and wherein the medical dialysis fluid generation systemincludes a second container placed fluidly in series or in parallel withthe first container. 75: The medical dialysis fluid generation system ofclaim 68, wherein the container is a first container, and which includesa second container placed fluidly in series with the first container anda third container placed fluidly in parallel with the first container.76: The medical dialysis fluid generation system of claim 68, whereinthe container is a first container, and wherein the medical dialysisfluid generation system includes a second container for receiving theperitoneal dialysis fluid, the medical dialysis fluid generation systemfurther including a first filling tube leading to the first containerand a second filling tube leading to the second container, and whereinthe medical dialysis fluid generation system includes either first andsecond clamps on the outside of the hemodialysis machine for selectivelyopening or occluding the first and second filling tubes, or a standalonevalve station for selectively opening or occluding the first and secondfilling tubes, wherein the standalone valve station is in wired orwireless communication with the control unit of the hemodialysis machinefor commanding the standalone valve station, the medical dialysis fluidgeneration system being configured to operate the standalone valvestation to deliver the peritoneal dialysis fluid in a first formulationto the first container and to deliver the peritoneal dialysis fluid in asecond formulation to the second container. 77: The medical dialysisfluid generation system of claim 68, further comprising a return linefrom the container to the hemodialysis machine for testing theperitoneal dialysis fluid, and wherein the testing includes compositionor sterility testing. 78: The medical dialysis fluid generation systemof claim 68, wherein the medical dialysis fluid generation systemincludes a heat sealer for sealing closed a filling line leading to thecontainer. 79: A medical fluid generation system comprising: waterpurification equipment configured to provide purified water; a containerfor storing medical fluid; a pressure transmission line in fluidcommunication with the container and configured to transmit a medicalfluid pressure; a concentrate for the medical fluid; and a hemodialysismachine in fluid communication with the water purification equipment,the hemodialysis machine including a pressure transducer positioned andarranged to sense the medical fluid pressure in the pressuretransmission line, a mixing pump for adding the concentrate with thepurified water to form the medical fluid, a dialysis fluid pump fordelivering the medical fluid to the container, and a control unitconfigured to (i) control the mixing pump to form the medical fluid,(ii) control the dialysis fluid pump to deliver the medical fluid to thecontainer, and (iii) look for a characteristic change in the medicalfluid pressure to stop the dialysis fluid pump from delivering themedical fluid to the container. 80: The medical fluid generation systemof claim 79, wherein the characteristic change in medical fluid pressureis a characteristic change in static medical fluid. pressure.